The Food and Drug Administration on Wednesday approved a first-ever injection treatment for severe frostbite that promises to prevent amputations of fingers and toes.
“Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes,” said Norman Stockbridge, FDA’s Director of the Division of Cardiology and Nephrology in the Center for Drug Evaluation and Research.
Although mild frostbite does not require medical intervention or cause permanent skin damage, severe frostbite can damage both the skin and underlying tissue due to the cold, limiting blood flow.
According to the FDA’s press release, the new drug Aurlumyn is a vasodilator, a drug that opens blood vessels and prevents clotting.
Although the Centers for Disease Control and Prevention does not have readily available data on the number of cases of frostbite in the United States, Canadian health officials have reported an increasing number of frostbite cases in recent years.
In the fiscal year 2022-2023, Calgary emergency rooms, urgent care centers, and advanced ambulatory centers reported 740 visits for frostbite. That’s up from a low of 396 visits in 2020-2021.
Clinical trials of Aurlumyn found that none of the patients treated with the drug for up to eight days needed an amputation. This is compared to 60% of frostbite patients not treated with the drug who eventually required an amputation.
The CDC warns that frostbite may be a sign of hypothermia, which is a more serious medical emergency that requires immediate medical attention.
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In cases of frostbite without hypothermia, the CDC recommends getting to a warm place as soon as possible but not using heating devices, such as a heating pad or fireplace, as affected areas may burn more easily.
Putting weight on frostbitten toes or fingers, such as through walking or massaging hands, can also result in more damage.
